A randomized phase III study evaluating pegylated liposomal doxorubicin versus capecitabine as first-line therapy for metastatic breast cancer: results of the PELICAN study.

PURPOSE: The PELICAN trial evaluates for the first time efficacy and safety of pegylated liposomal doxorubicin (PLD) versus capecitabine as first-line treatment of metastatic breast cancer (MBC). METHODS: This randomized, phase III, open-label, multicenter trial enrolled first-line MBC patients who were ineligible for endocrine or trastuzumab therapy. Cumulative adjuvant anthracyclines of 360 mg/m2 doxorubicin or equivalent were allowed. Left ventricular ejection fraction of >50 % was required. Patients received PLD 50 mg/m2 every 28 days or capecitabine 1250 mg/m2 twice daily for 14 days every 21 days. The primary endpoint was time-to-disease progression (TTP). RESULTS: 210 patients were randomized (n = 105, PLD and n = 105, capecitabine). Adjuvant anthracyclines were given to 37 % (PLD) and 36 % (capecitabine) of patients. No significant difference was observed in TTP [HR = 1.21 (95 % confidence interval, 0.838-1.750)]. Median TTP was 6.0 months for both PLD and capecitabine. Comparing patients with or without prior anthracyclines, no significant difference in TTP was observed in the PLD arm (log-rank P = 0.64). For PLD versus capecitabine, respectively, overall survival (median, 23.3 months vs. 26.8 months) and time-to-treatment failure (median, 4.6 months vs. 3.7 months) were not statistically significantly different. Compared to PLD, patients on capecitabine experienced more serious adverse events (P = 0.015) and more cardiac events among patients who had prior anthracycline exposure (18 vs. 8 %; P = 0.31). CONCLUSION: Both PLD and capecitabine are effective first-line agents for MBC.

Retrograde type a dissection in a 24th gestational week pregnant patient - the importance of interdisciplinary interaction to a successful outcome.

BACKGROUND: Type A Dissection in pregnancy is a devastating medical condition with 2 lives at stake and unclear strategy at early gestational stages. We describe a successful outcome, clearly dependent on the coordination of all involved disciplines. CASE PRESENTATION: This case history describes a 28 year old female with a 24th week pregnancy gravida 2 para 0 with a DeBakey Type I aortic dissection, diagnosed via ultrasound. Surgery was perfomed on the day of diagnosis. After conferral with the mother, caesarean section was performed and a 690 g fetus could be delivered and was immediately transferred to the neonatal unit. Subsequent aortic repair was performed after hysterectomy, with replacement of the ascending aorta and hemiarch treatment. Intraoperatively no entry in the ascending aorta or transverse arch could be demonstrated, so that a retrograde Type A with entry distal to the left subclavian had to be postulated. We decided to perform subsequent computer tomography, demonstrating multiple entry sites in the descending aorta distal to the left subclavian artery. Successful endovascular treatment could be performed with a Medtronic Valiant Stent via a transfemoral approach. The further hospital stay was uneventful and the patient could be discharged on the 18th postoperative day. The baby demonstrated fighter qualities and could be discharged home after a 3 month hospital stay to be reunited with his mother. CONCLUSION: Prompt diagnosis, precise coordination between all involved subspecialties and ultimately, as in this case, definitive treatment in consensus with operative and interventional departments have led to a successful outcome and encourages us in our daily struggle in this often demanding surgery.

Geriatric assessment and biomarkers in patients with metastatic breast cancer receiving first-line mono-chemotherapy: Results from the randomized phase III PELICAN trial.

OBJECTIVES: To determine predictive/prognostic factors for patients with metastatic breast cancer (MBC) receiving first-line monochemotherapy using biomarker analysis and geriatric assessment (GA). MATERIALS AND METHODS: Karnofsky Performance Status (KPS) and GA as clinical parameters, and prognostic inflammatory and nutritional index (PINI), and Glasgow prognostic score (GPS) as biomarkers were analyzed for association with clinical outcome within the randomized phase III PEg-LIposomal Doxorubicin vs. CApecitabin iN MBC (PELICAN) trial of first-line pegylated liposomal doxorubicin (PLD) or capecitabine. RESULTS: Of 210 patients, 38% were >65years old. GA (n=152) classified 74% as fit, 10% as compromised, and 16% as frail. Biomarkers showed no age dependency. In multivariate analysis (n=70) KPS, GA, cumulative illness rating scale-geriatrics (CIRS-G), and GPS were significantly associated with time to progression, and KPS, CIRS-G, and instrumental activities of daily living (IADL) from GA, and PINI showed a significant correlation with overall survival. CONCLUSION: GA evaluation was feasible. KPS significantly correlated with efficacy outcomes. Items of a GA and biomarkers of inflammation and nutrition may have prognostic significance in patients with MBC.

Dislocation of Intravenous Port Systems - Three Case Reports.

BACKGROUND: Many patients with intravenous chemotherapy have an intravenous port system because of high tissue toxicity of most chemotherapeutic agents in the case of paravasation. With more port systems implanted, the rate of complications is increasing. Apart from catheter thrombosis, we primarily know of fracture of the port catheter. CASE REPORT: We describe 3 patients of our chemotherapeutic clinic who experienced complications of the intravenous port system implanted in the vena brachialis. All of them showed fracture and loss of the port catheter, followed in some cases by symptoms such as cardiac problems. CONCLUSION: We have to discuss the use of intravenous port systems. Besides their comfortable use, intravenous port systems have to be handled with care and it has to be considered in every case if there really is the need for an implantation.

HINTERGRUND: Viele Patienten mit intravenöser Chemotherapie besitzen ein intravenös liegendes Portsystem aufgrund der hohen Gewebetoxizität der meisten Chemotherapeutika im Fall eines Paravasates. Je mehr Portsysteme implantiert werden, desto höher ist die Rate der Komplikationen; neben der Portvenenthrombose treten hauptsächlich Katheterkomplikationen auf. FALLBERICHT: Wir berichten von 3 Patientinnen aus unserer Chemoambulanz, die Komplikationen des Portsystems im Bereich der Vena brachialis zeigten, nämlich Katheterdislokationen, was sogar in einem Fall zu kardialen Symptomen geführt hat. ZUSAMMENFASSUNG: Man muss die Verwendung der intravenösen Portsysteme diskutieren. Insbesondere aufgrund des angenehmen Gebrauchs eines Ports muss dieser sorgfältig benutzt werden und in jedem Fall muss die Indikation zur Implantation neu gestellt werden.